Acupuncture as add-on to GCS-F Treatment for Reducing Febrile Neutropenia-related Hospitalization in Patients Undergoing Doxorubicin-based Treatment for Sarcoma: a Randomized Crossover Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Shaare Zedek Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Incidence of chemotherapy-induced febrile neutropenia-related hospitalization
Study Overview
Brief Summary
Chemotherapy-induced febrile neutropenia (CIFN) is a dangerous complication of many chemotherapy drugs, with current treatment with granulocyte colony-stimulating factors (G-CSFs) accompanied by adverse effects, primarily muscle and bone pain. Adult patients with sarcoma treated with doxorubicin-based chemotherapy have a high risk (>40%) for developing CIFN. Acupuncture has been shown to have a potentially myelo-protective effect on bone marrow during chemotherapy, though its effect on the incidence of CIFN-related hospitalization has yet to be examined. In the proposed study, patients with sarcoma will be randomly allocated (in a ratio of 1:1) to Group A, receiving acupuncture during cycles 1, 3, and 5; or Group B, during cycles 2, 4, and 6, with the study oncologist blinded regarding allocation. Acupuncture will be administered on the first day (d1) and the 8th day (d8) of the chemotherapy cycles, with press-tack needles on d1 to d8, and patients will be taught to self-treat with acupressure from d8 to the next cycle. The incidence and duration of hospitalization due to CIFN will be examined, as will adherence to the chemotherapy regimen; G-CSF-related pain; and other outcomes using 3 quality-of-life-focused questionnaires. The study findings will have important implications regarding the role of acupuncture in the treatment of patients treated with chemotherapy drugs with a high risk for CIFN, such as those used in the treatment of sarcoma.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Care Provider)
Masking Description
he treating oncologist will be blinded as to the patient's allocation and study intervention during each cycle of chemotherapy.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age 18-65 years
- •diagnosed with sarcoma of any stage
- •scheduled for doxorubicin-based chemotherapy
- •function ECOG status score of 0-1
Exclusion Criteria
- •not fulfilling all inclusion criteria
- •unwilling or unable to provide written informed consent for study participation
Arms & Interventions
Group A
Patients in Group A will undergo the acupuncture intervention at the 1st chemotherapy cycle; no acupuncture at the 2nd cycle; intervention at the 3rd; and so on.
Intervention: Acupuncture (Device)
Group B
No intervention at the 1st cycle; acupuncture intervention at the 2nd cycle; and so on.
Intervention: Acupuncture (Device)
Outcomes
Primary Outcomes
Incidence of chemotherapy-induced febrile neutropenia-related hospitalization
Time Frame: 3 weeks
Duration of chemotherapy-induced febrile neutropenia-related hospitalization
Time Frame: 3 weeks
Secondary Outcomes
- Quality of life-related outcomes: Quantitative Assessment(3 weeks)
- Quality of life-related outcomes: Qualitative Assessment(3 weeks)
- Relative Dose Intensity of Chemotherapy Regimen(3 weeks)
- G-CSF-related muscle and bone pain(3 wseks)
- Adverse effects of study intervention(3 weeks)
Investigators
Noah Samuels
Director, Center for Integrative Complementary Medicine
Shaare Zedek Medical Center